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Danaher Corporation Quality and Compliance Specialist in Rolling Meadows, Illinois

The Quality and Compliance Specialist is responsible for the Customer Care Quality Management System (QMS), owning global Standard Operating Procedures (SOP) and Work Instructions (WI). With good technical writing skills, the incumbent will draft procedures and other quality documentation to ensure adherence to Cepheid quality policies while making them simple to understand and be followed by team members all over the world. The position will lead QMS documentation improvement workshops and collaborate with regional experts to achieve the business objectives.

Essential Job Responsibilities:

  • Owns global Standard Operating Procedures (SOP) and Work Instructions (WI), ensuring procedures are up to date and reflect current business practices

  • Knowledge of QMS documentation standards; adheres to Cepheid’s documentation processes

  • Drafts QMS documents for Global Customer Care, and support Regional teams with local documentation

  • Administers the Document Control systems for in-scope documentation

  • Ensures alignment and consistency between the different hierarchy levels of QMS documentation

  • Provides training on QMS documentation

  • Manages requirements, risks, and implications of written documentation

  • Leads SOP overhaul workshops

  • Owns resolution of non-conformances, corrective and preventive actions (CAPA), and audit findings.

  • Supports internal and external audits

  • Is part of the compliance team – ensuring that SOPs and WIs are consistently followed

  • Supports other functions within Customer Care groups with the writing of QMS documents

  • Identifies solutions to support evolving business practices with compliant ways of doing things.

  • Collaborates across the organization at all levels and regional groups

  • Takes calculated risks and achieves balance business growth and compliance

  • Builds working relationship with other cross functional organizations that affect Customer Care operations, including Quality, Engineering, Supply Chain, Commercial Operations, and others.

  • Participates in Cepheid continuous improvement process in conjunction with all departments

Minimum Requirements:

Education or Experience (in years):

  • Bachelor’s degree with 5+ years of related work experience, OR

  • Master’s degree with 3+ years of related work experience.

Knowledge and Skills:

  • Experience with After Sales or Customer Service Quality systems and procedures

  • Experience in medical device industry preferred

  • Excellent communication skills; is sensitive to non-native English-speaking personnel – uses standard language to communicate effectively across all regions globally

  • Critical thinking – strong criteria to identify nuisances within written language that presents a gap, is conflicting, or otherwise not consistent

  • Strong team player with excellent interpersonal and communication skills

  • Experience of working in a complex matrix and global business environment

  • Knowledge of CFR Title 21 - Section 820.200 Servicing and Installation regulations a plus

  • Knowledge of ISO13485 – Medical Device Standards a plus

Travel

  • 5-10%

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When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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